Label: MEDICATED HEMORRHOIDAL PADS- witch hazel cloth

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated November 29, 2022

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  • Active ingredient

    Witch hazel 50%

  • Purpose

    Astringent

  • Uses

    • provides temporary relief of local itching and discomfort associated with hemorrhoids
    • temporary relief of irritation and burning.
    • aids in protecting irritated anorectal areas.
  • Warnings

    For external use only.

    When using this product

    • do not use more than directed unless told to do so by a doctor
    • do not put directly in the rectum by using fingers or any mechanical device or applicator.

    Stop use and ask a doctor if

    • bleeding occurs
    • condition worsens or does not improve within 7 days

    Keep out of reach of children.

    If swallowed, get medical help or contact Poison Control Center right away. (1-800-222-1222).

  • Directions

    adults:

    • cleane the affected area with mild soap and warm water, and rinse thoroughly
    • gently dry by patting or blotting with toilet tissue prior to applying.
    • apply externally to the affected area up to 6 times daily or after each bowel movement
    • dispose of pad in thrash after use and wash hands, do not flush

    children under 12 years of age: consult a doctor

  • Other Information

    • store at room temperature 15- 30 oC (59 - 86 oF)
    • for use as a moist compress - if necessary, first cleanse the area and place wipe in contact with irritated area for a soothing and cooling effect. Leave in place for up to 15 minutes and repeat as needed but not to exceed directions for use.
  • Inactive ingredients

    Water, Alcohol, Glycerin, Phenoxyethanol, Aloe, Decyl Glucoside, Potassium Sorbate, Propylene Glycol, Sodium Benzoate, Citric Acid.

  • Questions or Comments?

    (800) 320-6603

  • Principal Display Panel

    LEADER TM

    NDC 70000-0364-1

    Medicated Hemorrhoidal Pads

    WITCH HAZEL, 50% | Astringent

    Provides Immediate Relief from Itching and Burning Caused by Hemorrhoids

    Witch Hazel to Soothe and Protect Irritated Areas

    COMPARE TO TUCKS® MEDICATED COOLING PADS active ingredient*

    100% Money Back Guarantee

    100 PADS

    *This product is not manufactured or distributed by McNEIL-PPC, Inc., owner of the registered trademark Tucks® Medicated Cooling Pads.

    Label

  • INGREDIENTS AND APPEARANCE
    MEDICATED HEMORRHOIDAL PADS 
    witch hazel cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0364
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34) WITCH HAZEL500 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ALOE (UNII: V5VD430YW9)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0364-11 in 1 CARTON02/13/2019
    1100 in 1 JAR
    1200 mL in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34602/13/2019
    Labeler - Cardinal Health (063997360)
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